The Road to FDA Approval: Revogene’s Partnership with RND Group

 

Revogene® and RND Group

When medical device innovators need FDA compliant software, The RND Group is often at the top of recommended partners. Time and time again, RND Group clients report that their partnership with The RND Group helped keep their project’s software development on-schedule and within budget. The Revogene® team offers a similar report with their medical device’s FDA compliant software and verification project. Revogene® is focused on simplifying complex technology for its customers and they appreciated the streamlined process delivered by RND Group.

About Meridian Bioscience (acquired: GenePOC)

Meridian Bioscience, Inc. is devoted to pursuing a common, global cause: to simplify healthcare and improve the lives of patients and healthcare professionals worldwide. The company was first launched in 1977 when founder Bill Motto developed the innovative Para-Pak® transport system for safely handling patient samples. Over the next few years, Meridian’s research and development expanded even further.

In 1982, the company released a 10-minute rapid test for strep throat, which greatly reduced the standard two- to three-day wait time previously required before healthcare providers could review their patients’ results. Partly due to this success, Meridian Bioscience, Inc. went public in 1986.

In June of 2019, Meridian Bioscience achieved another important milestone through its acquisition agreement with GenePOC, a molecular diagnostic instruments and assays provider based in Québec City, Québec, Canada. GenePOC was also the original developer for the state-of-the-art Revogene® platform, which Meridian has proudly continued to develop and market with its robust commercial infrastructure. Today, the combined company employs more than 700 people globally. Meridian Bioscience, Inc. is headquartered in Cincinnati, Ohio, USA, and has offices in eight countries.

The Revogene® Solution

The idea for Revogene® first started with Dr. G. Michel Bergeron, the founder of GenePOC. His vision was to create a system that could save lives by bringing the sophistication of a medical lab closer to the patients. With this clear goal in mind, Dr. Bergeron went on to develop a standalone polymerase chain reaction (PCR) device that could be utilized at the point of care.

As with so many medical device solutions, the development process for Revogene® was intensive and called for collaboration across multiple disciplines and studies. The journey from product conception to real-world applications was long, but the team stayed focused because they knew they were working on a system that could consistently improve the lives of patients and their healthcare providers.

The whole life cycle of this project was nearly 8 years. The academic research and clinical trials took about 6 years, followed by 2 years for the development of the medical device and its software to get prepared for an FDA submission. Revogene® made its clinical debut in 2010.

The first assay for Revogene® was both submitted and accepted by the FDA in 2016. Since that time, up until the end of 2019, the FDA has reviewed and accepted another 3 assays to make a total of 4 approved by the FDA as of 2019. Now actively used in diverse clinical settings across the world, the Revogene® platform seamlessly offers diagnostics for single analyte tests, as well as flexible multiplex testing. These capabilities provide healthcare providers with a reliable, standardized process for detecting infectious disease and improving patient care with quick and effective treatment decisions. There is no denying the success of the Revogene® platform today—or how the right partnerships helped moved the device to market.

Software Partner Requirements

By working on such a revolutionary solution for automated diagnostics, the Revogene® team always knew that one of the key features of their device would be its software. In fact, as Sébastien Chapdelaine, team lead for Revogene® development and the Senior Director of R&D for Meridian Bioscience’s Diagnostics Department explains, “The software is the core of the instrument, from start to results and at each critical step of PCR.” Consequently, there was never any room for error. With so much at stake for the healthcare providers’ timelines and their patients’ crucial testing results, the Revogene® team knew they would need to identify the right strategic partnership for their software development.

In order to navigate this process, the Revogene® team developed a list of key criteria to help narrow down their search. Some of the most important factors for making their decision related to reputation, communication, and cost. Although they were considering two other software development subcontractors at the time, in the end, the Revogene® team decided to partner with The RND Group because they knew a high level of experience and expertise would be critical for developing a solution that would receive FDA approval.

Reputation and Track Record

It is important to note that client relationships with The RND Group often start long before a project is officially underway. This was certainly true for the Revogene® team. In fact, they first heard about RND through word-of-mouth, because the company name was mentioned several times among other professionals in their network. Being aware of RND’s name early on “gave us confidence in RND,” said Chapdelaine. “We knew the software would be looked at carefully, and we were confident with The RND Group’s quality system.”

Although aware of The RND Group for quite some time, the Revogene® team’s first interaction with the company wasn’t until 2013, when RND Vice President of Business Development, Tom Gardner, visited their booth at a trade show and started a friendly conversation. After the initial introductions, the relationship continued to grow for roughly two years with other discussions and check-ins before RND Group was hired to work on the Revogene® project.

Clear Communication and Responsiveness

One of the project details that stood out the most to the Revogene® team was the level of responsiveness they received from RND. They appreciated how their professionals would arrive early to meetings, and how the RND representatives, according to Chapdelaine, made a conscious effort to “do everything they need to do” to build a positive relationship.

During the software vendor selection process RND Group consistently made good impressions on the Revogene® team, but it was still important to consider other options. Unfortunately, interactions with other vendors were rarely as agreeable. “Others were much more aggressive,” said Chapdelaine. Rather than make an effort to reassure and encourage the Revogene® team throughout their conversations, the focus continued to loop back around to one question: “Do you have your requirements?” The other companies seemed to be more concerned with their developers’ needs—not how they could serve and collaborate with Revogene® for everyone’s benefit.

When reflecting on RND’s way of working with clients, Chapdelaine said, “RND was always working on the solution to get the right information to move forward.” Rather than demand that certain steps already be finished, RND was ready and willing to help get the Revogene® development where it needed to be in preparation for the next stage. “The communication was good and pleasant,” said Chapdelaine. When asked about RND’s responsiveness, he laughed. “It’s almost too fast at times!” But he admits that constant communication is one of the best ways to keep the project on track. Whenever concerns or questions arise, it was always helpful that everyone on the project was easy to reach.

Cost Analysis and Efficiency

As for the last key selection of criteria, the importance of following a budget was of vital importance for the Revogene® team. Being able to work with a software development company that stays within budget and communicates when scope changes were occurring was significant for reaching a successful outcome. Additionally, Revogene® needed to have confidence in the quality of the code being produced by the developers.

There was already a consensus in the Revogene® team’s professional network that RND had a strong track record with the FDA approval process. Nevertheless, the Revogene® team was keen on maximizing the return on their investment. “We’re always looking at cost,” said Chapdelaine. Yet they knew they could not make a decision on cost alone.

Chapdelaine and his team understood that having an efficient system for software development would ultimately help keep their project costs low. For RND, that means never needing to start coding from scratch. Instead, the developers can start from a proven application development framework and customize it for specific client projects like Revogene®. This is one of the most important differentiators for RND, and Chapdelaine cites this as one of the main reasons why they decided to select RND Group to champion the project. RND’s ability to work with reusable code and reconfigure software that has been part of the products previously approved by the FDA helped push the project forward and streamlined costs along the way.

Addressing Project Scope

Although the Revogene® team saw the benefits of RND’s unique application development framework upfront, like so many medical device teams, they still had a budget to follow throughout their software development process. Every complex project is bound to experience a few problems along the way. As Chapdelaine says, “The biggest challenge was never about an undelivered product.” The team wanted to stick to their budget in mind. Despite choosing RND because they believed in their cost-effective process, the Revogene® team still wondered whether they had underestimated their budget or not. Their team also questioned the chance of being surprised by an unexpected invoice.

Therefore, communication had such an influence over their decision to go with RND in the beginning. When they did run into a question about how to move forward with the budget, both sides were able to compromise and, as Chapdelaine explains, “meet halfway to get the work done and get our product on the market.”

For example, RND developed a new LIS communication protocol for the Revogene® project and RND wanted to retain joint ownership of this code. An arrangement to split the cost of developing this code was agreed to, with the cost of developing this specific code deferred to the end of the project. Chapdelaine offered this constructive comment: “Like all projects, there were some challenges on both sides. But in the end, we paid for the quality and this is what they delivered.”

The fact that navigating a discussion on the budget was the most difficult challenge throughout their partnership helped raise the Revogene® team’s confidence in RND’s process even more. Moreover, after that first submission, Chapdelaine said that the FDA’s questions had “did not raise a concern about the software.” He wondered whether that was because RND’s name recognition with the documentation they submitted. No matter the reason, “I just know that it went smoothly,” said Chapdelaine.

Expectations and Review

As the Revogene® team continued to reflect on their experience working with The RND Group, they stated that there were a few main takeaways from the partnership. For one, Chapdelaine said that RND “mastered the requirements.” He was also impressed with RND’s “flexibility to change the scope during the project.” Once again, the collaboration process was cited as a primary reason for how the relationship developed so well over the years.

“We had system requirements,” said Chapdelaine, “but they took two days just to sit with us and talk about the software requirements.” The fact that members of the RND team came to them in-person was particularly meaningful for the Revogene® team.

“We were having a fast-paced development with investors and we were trying to do a good job to define the requirements and apply them and deliver,” continued Chapdelaine. Because RND “knew exactly what to retest,” they were able to adapt to changes relatively smoothly.

This attention to detail helped keep their project on-time. While re-verifying software does have a cost, Chapdelaine once again acknowledged that “RND was efficient,” and the level of expertise from the developers and testers meant that there were not many issues to address with the software during that stage. Even with the two new releases of software, Chapdelaine said, “We were usually not waiting for RND.” The team was diligent about respecting the Revogene® team’s timeline and budget, and that went a long way in ensuring the project’s overall success.

Conclusion: Efficient Workflow

Since it was first released in 2016, Revogene® has continued to be adopted by healthcare organizations at a rapid pace. This increase in adoption is a true testament to everyone who worked to bring this to the market, from that initial project idea to the new tests and additions to come. It has never been a question that innovation and a passion for improving the lives of others are certainly at the core of the Revogene® system.

Chapdelaine and his team selected The RND Group to help complete the software development because they were confident that their process would be efficient—similar to how Revogene® functions. RND Group also supplied the necessary verification and submission documentation for Revogene®’s formal FDA approval process. From start the finish, the partnership was both cooperative and productive.

“During the early phase of the development, The RND Group started promptly and took the lead,” said Chapdelaine. “We learned a lot from them and from their framework.” When asked whether RND delivered on their promises, Chapdelaine said, “Absolutely. RND met and overpassed our expectations.”

For more information about Meridian Bioscience and Revogene®, please visit www.meridianbioscience.com or contact Sébastien Chapdelaine directly at [email protected]

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